Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery - Randomized Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer

Japanese Gynecologic Oncology Group0 sites360 target enrollmentJuly 20, 2012

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stage I epithelial ovarian cancer after comprehensive staging surgery
Sponsor: Japanese Gynecologic Oncology Group
Enrollment: 360
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

July 20, 2012

End Date

July 1, 2029

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

•1\) FIGO Stages IC2, IC3 2\) Patients containing sarcoma elements 3\) Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT 4\) Patients with serious complications 5\) Patients with active infection 6\) Patients with intestinal paralysis or intestinal obstruction 7\) Patients who have a synchronous malignancy or who have been progression\-free less than 5 years for a metachronous malignancy 8\) Patients with previous chemotherapy or radiation therapy 9\) Patients with serious drug hypersensitivity 10\) Patients with peripheral motor/sensory neuropathy (grade2,3,4 CTC\-AE 4\.0\) 11\) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 12\) Patients with positive HBsAg.Patients with more than 2\.1 log/copies ml based on fixed HBV\-DNA who are positive with either antigen\-positive HBs, anti\-hepatitis B core antigen or anti\-hepatitis B surface antigen. 13\) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician